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Completed

NCT Number: NCT01374542

Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy. The diagnostic yield, technical factors and complications for all patient sub-populations is still not clearly defined. This may result in inappropriate or even dangerous application of such procedures. The aim of the study is to collect data on these aspects of respiratory endoscopy and identify important trends, as well as, areas for improvement. This data will also provide baseline comparative data for new bronchoscopic techniques such as endobronchial ultrasound and navigational bronchoscopy.

Method: Prospective data collection. Technical details regarding these procedures are currently keyed into the OTM system by the endoscopy operators for documentation and billing. The department of Respiratory and Critical Care Medicine gets monthly downloads of all the fields from the OTM system for audit purposes.(See data collection form) The research project proposes to make the data non identifiable by removing the patient's name and IC number. Additionally the yield of the procedure will be checked by a chart review of the histology and microbiology results. There are no restrictions on patient recruitment because all procedures will be performed for clinical indications only and no patient will be recruited for the sole purpose of the study. Waiver of consent has been approved by the IRB.

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Key information

Age range

10 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore General Hospital

Singapore, 168753

About this study

Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy. The diagnostic yield, technical factors and complications for all patient sub-populations is still not clearly defined. This may result in inappropriate or even dangerous application of such procedures. The aim of the study is to collect data on these aspects of respiratory endoscopy and identify important trends, as well as, areas for improvement. This data will also provide baseline comparative data for new bronchoscopic techniques such as endobronchial ultrasound and navigational bronchoscopy.

Method: Prospective data collection. Technical details regarding these procedures are currently keyed into the OTM system by the endoscopy operators for documentation and billing. The department of Respiratory and Critical Care Medicine gets monthly downloads of all the fields from the OTM system for audit purposes.(See data collection form) The research project proposes to make the data non identifiable by removing the patient's name and IC number. Additionally the yield of the procedure will be checked by a chart review of the histology and microbiology results. There are no restrictions on patient recruitment because all procedures will be performed for clinical indications only and no patient will be recruited for the sole purpose of the study. Waiver of consent has been obtained by the IRB. The current estimated bronchoscopy load is 1000/year and data will be kept in the trial co-coordinator's computer in a locked office. The investigators hope to run the database for 3 years initially.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing respiratory endoscopy at Singapore General Hospital

Exclusion criteria

  • Clinical contra-indications to respiratory endoscopy

Treatment and study plan

Respiratory endoscopy

Procedure

Bronchoscopy, thoracoscopy, endobronchial ultrasound

Other names: Bronchoscopy-Flexible bronchoscopy, Thoracoscopy-Pleuroscopy, Endobronchial ultrasound-EBUS

Primary outcomes

  1. Endoscopy diagnostic yield

    Time frame: 1 year

    Positive and negative histology and microbiology yield

  2. Endoscopy technical factors

    Time frame: 1 year

    Duration, sedation requirements, consumables

  3. Endoscopy safety

    Time frame: 1 year

    Complication rate, need for escalation of care

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2011
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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